Towards an ethics safe harbor for global biomedical research

E. S. Dove, B. M. Knoppers, M. H. Zawati

Research output: Contribution to journalArticlepeer-review


Although increasingly global, data-driven genomics and other ‘omics’-focused research hold great promise for health discoveries, current research ethics review systems around the world challenge potential improvements in human health from such research. To overcome this challenge, we propose a ‘Safe Harbor Framework for International Ethics Equivalency’ that facilitates the harmonization of ethics review of specific types of data-driven international research projects while respecting globally transposable research ethics norms and principles. The Safe Harbor would consist in part of an agency supporting an International Federation for Ethics Review (IFER), formed by a voluntary compact among countries, granting agencies, philanthropies, institutions, and healthcare, patient advocacy, and research organizations. IFER would be both a central ethics review body, and also a forum for review and follow-up of policies concerning ethics norms for international research projects. It would be built on five principle elements: (1) registration, (2) compliance review, (3) recognition, (4) monitoring and enforcement, and (5) public participation. The Safe Harbor would create many benefits for researchers, countries, and the general public, and may eventually have application beyond (gen)omics to other areas of biomedical research that increasingly engage in secondary use of data and present only negligible risks.
Original languageEnglish
Pages (from-to)3-51
Number of pages49
JournalJournal of Law and the Biosciences
Issue number1
Publication statusPublished - 14 Feb 2014


  • biomedical research
  • ethics
  • genomics
  • governance
  • harmonization
  • safe harbor


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